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出境医 / 临床实验 / Treatment Safety and Efficacy of Pro-ocular™ 1% for Chronic Ocular Graft Following Allogeneic HSCT.
Treatment Safety and Efficacy of Pro-ocular™ 1% for Chronic Ocular Graft Following Allogeneic HSCT.
Study Description
Brief Summary:
To evaluate the safety and efficacy of Pro-ocular™ 1% topical gel administered twice daily for 70 days in reducing or eliminating symptoms and signs of chronic ocular GvHD.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Chronic Ocular Graft-versus-host Disease | Drug: Pro-ocular™ topical gel Drug: Placebo topical gel | Phase 2 |
Detailed Description:
Ocular graft versus host disease presents a most severe form of ocular surface disease that compromises quality of life of afflicted allogeneic hematopoietic transplantation patients.
A controlled study is necessary to verify findings obtained to date in isolated patients. Currently available ophthalmic solutions and suspensions, drugs and devices largely have not been effective in alleviating the suffering of chronic ocular GvHD patients. Thus, this is an unmet need that Pro-ocular™ topical gel can fulfill.
Potential benefits: Decrease or cessation of adverse ocular symptoms and signs of chronic ocular GvHD, reduction or elimination of the need for other topical ocular therapeutic treatments for chronic ocular GvHD, and restoration of quality of life.
Study Design
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 33 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Intervention Model Description: | The double-masked phase involves placebo controlled administration of study drug for 70 days or 10 weeks. Subsequently the placebo group will receive the active study drug of 42 days or 6 weeks. Long term open label phase to 27 months. |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Masking Description: | Randomized double-masked parallel treatment assignment will be made using a block design at the ratio of 2:1, study drug:placebo, (22 subjects:11 subjects). This 70-day double-masked phase will be followed by 6 weeks open-label active drug treatment of the subjects previously on placebo. |
| Primary Purpose: | Treatment |
| Official Title: | Treatment Safety and Efficacy Using Pro-ocular™ 1% for Chronic Ocular Graft-versus-host Disease (GvHD) Following Allogeneic Hematopoietic Stem Cell Transplantation. |
| Actual Study Start Date : | October 17, 2019 |
| Estimated Primary Completion Date : | October 31, 2021 |
| Estimated Study Completion Date : | November 19, 2021 |
Arms and Interventions
| Arm | Intervention/treatment |
|---|---|
|
Experimental: Pro-ocular™
Pro-ocular™ 1% topical gel applied dermally to forehead twice daily, morning and before bedtime.
|
Drug: Pro-ocular™ topical gel
Topical gel for forehead dermal application
|
|
Placebo Comparator: Placebo
Vehicle topical gel without active ingredient applied dermally to forehead twice daily, morning and before bedtime.
|
Drug: Placebo topical gel
Topical gel for forehead dermal application
|
Outcome Measures
Primary Outcome Measures :
- Ocular pain from Glia OSD Symptoms Questionnaire [ Time Frame: 1 hour ]Change in ocular pain score
- Ocular discomfort [ Time Frame: 1 hour ]Change in ocular discomfort score
- Ocular discomfort [ Time Frame: 2 weeks ]Change in ocular discomfort score
- Corneal fluorescein staining [ Time Frame: 10 weeks ]Change in fluorescein staining score
- Conjunctival staining [ Time Frame: 10 weeks ]Change in conjunctival staining score
Secondary Outcome Measures :
- Modified SANDE [ Time Frame: 2 weeks ]Change in SANDE score
- Modified SANDE [ Time Frame: 6, 10 weeks ]Change in SANDE score
- Modified SANDE [ Time Frame: 10 weeks ]Change in SANDE score
- Glia OSD Symptoms Questionnaire [ Time Frame: 1 hour ]Change in total score
- Glia OSD Symptoms Questionnaire [ Time Frame: 2 weeks ]Change in total score
- Glia OSD Symptoms Questionnaire [ Time Frame: 6 weeks ]Change in total score
- Glia OSD Symptoms Questionnaire [ Time Frame: 10 weeks ]Change in total score
- Tear Film [ Time Frame: 1 hour ]Change in tear film score
- Tear Film [ Time Frame: 2 weeks ]Change in tear film score
- Tear Film [ Time Frame: 6 weeks ]Change in tear film score
- Tear Film [ Time Frame: 10 weeks ]Change in tear film score
- Conjunctival staining [ Time Frame: 6 ]Change in conjunctival staining score
- Lid margin [ Time Frame: 6 weeks ]Change in lid margin abnormality score
- Lid margin [ Time Frame: 10 weeks ]Change in lid margin abnormality score
- Ocular pain from Glia OSD Symptoms Questionnaire [ Time Frame: 2 weeks ]Change in ocular pain score
- Ocular pain from Glia OSD Symptoms Questionnaire [ Time Frame: 10 weeks ]Change in ocular pain score
- Ocular pain from Glia OSD Symptoms Questionnaire [ Time Frame: 6 weeks ]Change in ocular pain score
- Ocular discomfort [ Time Frame: 6 weeks ]Change in ocular discomfort score
- Ocular discomfort [ Time Frame: 10 weeks ]Change in ocular discomfort score
- Corneal fluorescein staining [ Time Frame: 6 weeks ]Change in fluorescein staining score
- NIH Chronic GvHD Eye Score [ Time Frame: 2 weeks ]Change in eye score
- NIH Chronic GvHD Eye Score [ Time Frame: 6 weeks ]Change in eye score
- NIH Chronic GvHD Eye Score [ Time Frame: 10 weeks ]Change in eye score
Eligibility Criteria
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Male or female of any race, at least 18 years of age at Visit 1 Screening.
- Has the diagnosis of chronic ocular GvHD.
- Has an NIH Consensus Eye Score of at least 2.
- On the GLIA Ocular Surface Disease Symptoms Questionnaire at Screening, has ocular discomfort at a severity score of moderate or more, and at least one other symptom at a severity of moderate or more.
- One or more signs from the list of chronic ocular GvHD signs below
- Has provided verbal and written informed consent.
- Be able and willing to follow oral and written instructions, including participation in all study assessments and visits.
Exclusion Criteria:
- Wearing scleral or contact lenses within the last month, or those who plan to start wearing scleral or contact lenses during the study.
- Anticipate major changes in systemic GvHD management during study period.
- Comorbidity with other severe or chronic eye conditions that in the judgment of the investigator will interfere with study assessments, such as but not limited to retinal detachment, recent ocular surgery, Bell's palsy, active trigeminal neuritis or trigeminal neuralgia.
- Anticipate change of vision correction or anticipate any ocular procedures during study period.
- A woman who is pregnant, nursing an infant, or planning a pregnancy.
- A woman of childbearing potential who has a positive urine pregnancy test at Visit 1, or who does not use an adequate method of birth control throughout the study period.
- Has a known adverse reaction and/or sensitivity to the study drug or its components.
- Unwilling to cease the use of sunscreen on the forehead or eye area.
- Intraocular pressure >22 mm Hg at screening visit with or without ongoing glaucoma treatment.
- Currently enrolled in an investigational drug or device study for chronic ocular GvHD.
Contacts and Locations
Locations
| United States, Massachusetts | |
| Massachusetts Eye and Ear Longwood | |
| Boston, Massachusetts, United States, 02115 | |
Sponsors and Collaborators
Glia, LLC
ORA, Inc.
Investigators
| Principal Investigator: | Zhonghui K Luo, MD, PhD | Massachusetts Eye and Ear, Longwood |
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date ICMJE | June 11, 2019 | ||||
| First Posted Date ICMJE | June 18, 2019 | ||||
| Last Update Posted Date | March 16, 2021 | ||||
| Actual Study Start Date ICMJE | October 17, 2019 | ||||
| Estimated Primary Completion Date | October 31, 2021 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
|
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | |||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Treatment Safety and Efficacy of Pro-ocular™ 1% for Chronic Ocular Graft Following Allogeneic HSCT. | ||||
| Official Title ICMJE | Treatment Safety and Efficacy Using Pro-ocular™ 1% for Chronic Ocular Graft-versus-host Disease (GvHD) Following Allogeneic Hematopoietic Stem Cell Transplantation. | ||||
| Brief Summary | To evaluate the safety and efficacy of Pro-ocular™ 1% topical gel administered twice daily for 70 days in reducing or eliminating symptoms and signs of chronic ocular GvHD. | ||||
| Detailed Description |
Ocular graft versus host disease presents a most severe form of ocular surface disease that compromises quality of life of afflicted allogeneic hematopoietic transplantation patients. A controlled study is necessary to verify findings obtained to date in isolated patients. Currently available ophthalmic solutions and suspensions, drugs and devices largely have not been effective in alleviating the suffering of chronic ocular GvHD patients. Thus, this is an unmet need that Pro-ocular™ topical gel can fulfill. Potential benefits: Decrease or cessation of adverse ocular symptoms and signs of chronic ocular GvHD, reduction or elimination of the need for other topical ocular therapeutic treatments for chronic ocular GvHD, and restoration of quality of life. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase ICMJE | Phase 2 | ||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Intervention Model Description: The double-masked phase involves placebo controlled administration of study drug for 70 days or 10 weeks. Subsequently the placebo group will receive the active study drug of 42 days or 6 weeks. Long term open label phase to 27 months. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)Masking Description: Randomized double-masked parallel treatment assignment will be made using a block design at the ratio of 2:1, study drug:placebo, (22 subjects:11 subjects). This 70-day double-masked phase will be followed by 6 weeks open-label active drug treatment of the subjects previously on placebo. Primary Purpose: Treatment
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| Condition ICMJE | Chronic Ocular Graft-versus-host Disease | ||||
| Intervention ICMJE |
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| Study Arms ICMJE |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Estimated Enrollment ICMJE |
33 | ||||
| Original Estimated Enrollment ICMJE | Same as current | ||||
| Estimated Study Completion Date ICMJE | November 19, 2021 | ||||
| Estimated Primary Completion Date | October 31, 2021 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||
| Accepts Healthy Volunteers ICMJE | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Listed Location Countries ICMJE | United States | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT03990051 | ||||
| Other Study ID Numbers ICMJE | oGvHD-1 | ||||
| Has Data Monitoring Committee | Yes | ||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE |
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| Responsible Party | Glia, LLC | ||||
| Study Sponsor ICMJE | Glia, LLC | ||||
| Collaborators ICMJE | ORA, Inc. | ||||
| Investigators ICMJE |
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| PRS Account | Glia, LLC | ||||
| Verification Date | March 2021 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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